Pitavastatin represents important treatment option for more vulnerable populations

BOSTON, June 16 /PRNewswire/ -- New data presented today showed that pitavastatin is an effective treatment for the management of dyslipidemia in elderly patients, with a similar safety and tolerability profile to low-dose pravastatin. The Phase III data were presented today by Kowa, at the XV International Symposium on Atherosclerosis in Boston.

"This study shows the effectiveness of pitavastatin to lower LDL [low-density lipoprotein] cholesterol in a group of elderly patients with primary hypercholesterolemia or combined dyslipidemia," said Professor Steen Stender, M.D., Ph.D., Gentofte University Hospital, Denmark, and an investigator for the study. "When compared to the usual daily dosage of 40 mg pravastatin, a 4-mg dosage of pitavastatin demonstrated greater LDL-cholesterol lowering with no significant safety difference across all doses, and may represent a more favorable treatment option for such target populations."

The Phase III, active-controlled study was conducted for 12 weeks to compare the safety and efficacy of pitavastatin (1 mg, 2 mg and 4 mg) and pravastatin (10 mg, 20 mg and 40 mg) in patients aged more than or equal to 65 years with primary hypercholesterolemia or combined dyslipidemia. About half of the patients had hypertension, 5 percent had diabetes and about 80 percent were taking concomitant medications. A 60-week, open-label extension to this core study was conducted to assess the long-term safety of pitavastatin at the recommended starting dose of 2 mg once daily, and the need for up-titration to 4 mg once daily in consenting completers from the pitavastatin treatment groups of the core study.

The results of the core study demonstrated that pitavastatin was statistically superior to pravastatin across all three dose comparisons as measured by percent change from baseline in LDL-C (P<.001), and that a higher percentage of patients achieved LDL-C goal with pitavastatin 2 mg and 4 mg than in any other treatment group. All three doses of pitavastatin demonstrated a comparable safety profile to low-dose pravastatin. In addition, results from the extension study showed maintenance of the efficacy and safety of pitavastatin 2 mg and 4 mg through 60 weeks.

"The results of this study show that pitavastatin has a robust efficacy, safety and tolerability profile at the proposed starting dose and offers a low-dose alternative for vulnerable populations, such as the elderly," said Neil Hounslow, vice president of scientific affairs, Kowa Research Europe. "It may be difficult to choose a suitable statin for elderly patients with primary hypercholesterolemia or combined dyslipidemia who are taking other medications, and this study demonstrates that the majority of these patients can achieve and sustain goal with the starting dose of 2 mg of pitavastatin once daily."

About pitavastatin

Pitavastatin (a statin) is a fully synthetic and highly potent inhibitor of HMG-CoA reductase used for primary hypercholesterolemia and combined dyslipidemia. Pitavastatin has a unique cyclopropyl group on the base structure common to the statin class. Since its 2003 launch in Japan, pitavastatin has accumulated millions of patient-years of exposure. Many of these patients have comorbidities and are taking multiple medications. Kowa has filed a New Drug Application for pitavastatin with the U.S. Food and Drug Administration and expects a response from the agency in Q3 of 2009. Once approved, pitavastatin will be available in the United States in three dosage strengths (1, 2 and 4 mg).

About Kowa Company Ltd. and Kowa Pharmaceuticals America, Inc.

Kowa Company, Ltd. is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products. Kowa's pharmaceutical division is focused on cardiovascular therapeutics, with fiscal year 2008 sales of the company's flagship product, LIVALO(R) (pitavastatin) totaling $340 million in Japan.

Kowa Pharmaceuticals America, Inc. is a specialty pharmaceutical company focused primarily in the area of cardiology. The company, started in 2001 as ProEthic Pharmaceuticals, Inc., was acquired by Kowa Company, Ltd. in September of 2008. A privately held company, KPA focuses its efforts on the acquisition, development, licensing and marketing of pharmaceutical products. Its lead product, LIPOFEN(R) (fenofibrate capsules), is indicated as adjunctive therapy to diet to reduce elevated triglycerides and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidemia.

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